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DRUG CLASS:

CD22-targeted antibody-drug conjugate

1d
Trial completion
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CD22 (CD22 Molecule)
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CD22 positive
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Besponsa (inotuzumab ozogamicin)
1d
Evaluation of multi-antigen targeting ADCC strategies in pediatric BCP-ALL. (PubMed, J Immunother Cancer)
CD24 therefore emerged as an effective target in BCP-ALL, and the combination of CD24 and CD123 as a potential effective double-targeting strategy. The combination of different recognition modalities (eg, a CAR and CD16) should be tested to determine whether it provides synergistic cytotoxic activity in triple targeting.
Journal
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CD123 (Interleukin 3 Receptor Subunit Alpha) • CD24 (CD24 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • ADAM10 (ADAM Metallopeptidase Domain 10) • ADAM8 (ADAM Metallopeptidase Domain 8)
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
2d
Impact of TP53 mutations and their variant allele frequency in adults with newly diagnosed acute lymphoblastic leukemia. (PubMed, Blood)
Patients ≥60 years with Ph-negative B-cell ALL and TP53 VAF ≥45% had poor outcomes, with 4-year event-free survival (EFS) and overall survival (OS) of 28%, driven primarily by increased relapse risk, even among patients treated with frontline inotuzumab ozogamicin (INO) and/or blinatumomab. TP53 persistence at remission occurred in 44% of tested patients and was associated with increased ALL relapse risk. These results demonstrate that TP53 VAF is prognostic in older patients with Ph-negative B-cell ALL; high VAF may increase relapse risk but is not independently associated with survival in younger patients.
Journal
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TP53 (Tumor protein P53)
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TP53 mutation • TP53 wild-type
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
3d
AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=80, Recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
Trial completion date • Trial primary completion date
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CD22 (CD22 Molecule)
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cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate)
10d
NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=37, Terminated, M.D. Anderson Cancer Center | Active, not recruiting --> Terminated; <75% participation
Trial termination
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CD22 (CD22 Molecule)
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epratuzumab-cys-tesirine (ADCT-602)
13d
Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL (clinicaltrials.gov)
P2, N=42, Recruiting, Sheng-Li Xue, MD | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Minimal residual disease
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ABL1 (ABL proto-oncogene 1) • CD22 (CD22 Molecule)
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Besponsa (inotuzumab ozogamicin)
14d
A Multi-center Retrospective Study of INO Treating B-ALL (clinicaltrials.gov)
P=N/A, N=102, Active, not recruiting, Ruijin Hospital
New trial
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Besponsa (inotuzumab ozogamicin)
15d
The emerging role of immunotherapy in improving outcomes in Down syndrome - associated acute lymphoblastic leukemia: an insightful review. (PubMed, Leuk Lymphoma)
Recent advances in immunotherapy, including blinatumomab, inotuzumab ozogamicin, and CD19-directed CAR T-cell therapy, have shown significant efficacy and favorable tolerability in pediatric and adult DS-ALL. Emerging approaches incorporating early immunotherapy, MRD-guided treatment, and chemotherapy-free regimens may improve survival and quality of life. Prospective DS-specific trials are essential to optimize therapy and close the outcome gap in this high-risk population.
Review • Journal • IO biomarker
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ABL1 (ABL proto-oncogene 1) • CRLF2 (Cytokine Receptor Like Factor 2)
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
15d
Efficacy and safety of inotuzumab ozogamicin and its combination therapies in acute lymphoblastic leukemia: a systematic review and meta-analysis. (PubMed, Front Oncol)
Further randomized studies are needed to validate these findings. https://www.crd.york.ac.uk/prospero/, identifier CRD42024619042.
Retrospective data • Review • Journal
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CD22 (CD22 Molecule)
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Besponsa (inotuzumab ozogamicin)
17d
Enrollment change • Minimal residual disease
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Besponsa (inotuzumab ozogamicin)
1m
NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=57 --> 37
Enrollment closed • Enrollment change
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CD22 (CD22 Molecule)
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epratuzumab-cys-tesirine (ADCT-602)